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Advice from the Therapeutic Goods Administration, listed in date order (most recent first).
GlaxoSmithKline (GSK) and Alphapharm, in consultation with the Therapeutic Goods Administration, are undertaking a voluntary recall of several batches of Ventolin and Asmol inhalers due to a fault in the delivery mechanism of a small number of inhalers within each batch. This can lead to less than the full dose being delivered for each puff.
The only batches affected are as follows:
- Ventolin Batch numbers KN7170, KN7173, KN7178, and KN7179
- Asmol Batch Numbers KL6790, KL6795, KL6796, KL6797, KL6798, and KL6799
The recall notice is published on the Therapeutic Goods Administration website at http://www.tga.gov.au/safety/alerts-medicine-ventolin-asmol-121224.htm
TGA advises of new requirements for OTC cough and cold medicines for children effective from 1 September 2012:
- These medicines should not be given to children under six years of age; and
- If they are indicated for children six to 11 years, they should only be given on the advice of a doctor, pharmacist or nurse practitioner.
- There are no scheduling changes to these products.
- There will be products with existing labels as well as products with new labels in the marketplace. There is no plan to recall products with the existing labels and they may remain in the market until they reach their expiry date.
- New products will have child-resistant packaging.
PSA has developed a fact sheet detailing the affected products, with scenarios to assist pharmacists with communicating this information to patients. Page 1 of the factsheet can be printed and kept in the pharmacy to help you explain these changes when counselling patients.
If you are a PSA member but cannot see a link to the factsheet below, you need to log in first.
This item is listed in the following categories: • Guidelines